Covid19 Clinical Trial
— IMPSY-COVOfficial title:
Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area : a Prospective Longitudinal Study by Self-administered Questionnaires
Evaluation of the psychological impact of the COVID-19 pandemic on hospital staff in the French Nouvelle Aquitaine area, through a longitudinal study with repeated self-administered psychologic scales
Status | Not yet recruiting |
Enrollment | 8000 |
Est. completion date | December 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or more - hospital workers exposed to COVID-19 - consented to participate to the study - master the french langage - Understanding of type, objectives and study methology - accept an on-line evaluation - Benefit from health insurance Exclusion Criteria: - refuse to participate - pregnant or breastfeeding woman - Be under measure of legal protection: guardianship, curatorship or safeguard of justice. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Charles Perrens, Bordeaux | Région Nouvelle Aquitaine, Regional Health Agency New Aquitaine |
Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. — View Citation
Chua SE, Cheung V, Cheung C, McAlonan GM, Wong JW, Cheung EP, Chan MT, Wong MM, Tang SW, Choy KM, Wong MK, Chu CM, Tsang KW. Psychological effects of the SARS outbreak in Hong Kong on high-risk health care workers. Can J Psychiatry. 2004 Jun;49(6):391-3. — View Citation
Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. — View Citation
Johnson EI, Grondin O, Barrault M, Faytout M, Helbig S, Husky M, Granholm EL, Loh C, Nadeau L, Wittchen HU, Swendsen J. Computerized ambulatory monitoring in psychiatry: a multi-site collaborative study of acceptability, compliance, and reactivity. Int J Methods Psychiatr Res. 2009;18(1):48-57. doi: 10.1002/mpr.276. — View Citation
Luceño-Moreno L, Talavera-Velasco B, García-Albuerne Y, Martín-García J. Symptoms of Posttraumatic Stress, Anxiety, Depression, Levels of Resilience and Burnout in Spanish Health Personnel during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Jul 30;17(15). pii: E5514. doi: 10.3390/ijerph17155514. — View Citation
Mohammed A, Sheikh TL, Poggensee G, Nguku P, Olayinka A, Ohuabunwo C, Eaton J. Mental health in emergency response: lessons from Ebola. Lancet Psychiatry. 2015 Nov;2(11):955-7. doi: 10.1016/S2215-0366(15)00451-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in anxiety disorder overcome | GAD-7 score:
> 7 , the anxiety disorder status is "supected", [5; 9] corresponds to anxiety evaluation: "light" [10; 14] corresponds to anxiety evaluation: "moderate" > 15, corresponds to anxiety evaluation: "severe" |
inclusion, month 1, month 3, month 6, month 12 | |
Primary | Changes in anxiety disorder overcome | PDSR verifies that maximum of the panic state is reached within ten minutes | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Determination and collection of lived traumatic events types | Life Events Checklist for DSM-5 (LEC-5) | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Posttraumatic stress disorder symptoms presence and measurment | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) PCL-5 score > 32 indicate presence of Posttraumatic Stress Trouble (PST) | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | 2-last-week mood assessment | Beck Depression Inventory - Fast Screen - France (BDI-FS FR) score > 13 indicates presence of a depressive trouble | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Identification of coping pattern to stress | Coping Inventory for Stressful Situations (CISS) questionnaire Participant assess from 'little" to "a lot" his tendency to adopt a task, emotion or behaviour based pattern | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Burn out diagnosis | MASLACH BURNOUT INVENTORY (MBI questionnaire) assessment of the 3 aspects from low to high
burn out feeling deshumanisation accomplishment at work |
inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Self evaluation of state of health | considering the 4-last-weeks the participant will assess 8 under-scales for score 0 to 100 (favourable) | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Psycho active drugs intakes and level of intake over the last month | selection of the drug and level of intake will n*be assessed 'none', "new", "increasing", constant" | inclusion, month 1, month 3, month 6, month 12 | |
Secondary | Evaluation of the CUMP support to health professionnals | answer "yes' or "no" support has been contacted already or since the last study assessement | inclusion, month 1, month 3, month 6, month 12 |
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